FDA Inspection 921846 — Hawknad Manufacturing Industries, Inc.
The FDA completed an inspection of Hawknad Manufacturing Industries, Inc. on April 23, 2015 in Alexandria, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alexandria, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4576 | 21 CFR 211.192 | No written record of investigation |